Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
33995 participants
INTERVENTIONAL
2018-05-08
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Experimental Group
Village-doctor-led multifaceted intervention
Village-doctor-led multifaceted intervention
* Establishing a network including hypertension specialists at city/county hospitals, primary care physicians at township hospitals, and village doctors to collaboratively manage hypertension
* Using hypertension control rate as one of the metrics for incentive supplements to village doctors
* Providing discounted or free antihypertensive medications to patients with hypertension
* Training village doctors to measure blood pressure according to a standard protocol
* Training village doctors to use a simple stepwise protocol for hypertension treatment
* Training village doctors to conduct health coaching on lifestyle change (e.g., lowering sodium and alcohol intake) and medication adherence
* Providing free blood-pressure monitor and training to patients for home blood pressure measurement
* Encouraging lifestyle change and medication adherence
* Connecting patients through WeChat or telephone for group social support
Control Group
Village doctors in usual care group will not receive hypertension management training or support. However, they will be trained in standardized BP measurement. Participants in control group will receive their usual care from village doctors or primary care physicians in township hospitals
No interventions assigned to this group
Interventions
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Village-doctor-led multifaceted intervention
* Establishing a network including hypertension specialists at city/county hospitals, primary care physicians at township hospitals, and village doctors to collaboratively manage hypertension
* Using hypertension control rate as one of the metrics for incentive supplements to village doctors
* Providing discounted or free antihypertensive medications to patients with hypertension
* Training village doctors to measure blood pressure according to a standard protocol
* Training village doctors to use a simple stepwise protocol for hypertension treatment
* Training village doctors to conduct health coaching on lifestyle change (e.g., lowering sodium and alcohol intake) and medication adherence
* Providing free blood-pressure monitor and training to patients for home blood pressure measurement
* Encouraging lifestyle change and medication adherence
* Connecting patients through WeChat or telephone for group social support
Eligibility Criteria
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Inclusion Criteria
* The village has a regular village doctor who is willing to participate in the hypertension control project
* The village does not plan to merge with other villages within 3 years
* The village is at least 2 kilometers away from other participating villages
* The village participates in the China New Rural Cooperative Medical Scheme
Eligibility criteria of study participants:
* Men or women aged ≥40 years
* Mean untreated systolic BP ≥140 mm Hg and/or diastolic BP ≥90 mm Hg or mean treated systolic BP ≥130 mm Hg and/or diastolic BP ≥80 mm Hg for individuals without a history of clinical CVD; or mean treated/untreated systolic BP ≥130 mm Hg and/or diastolic BP ≥80 mm Hg for individuals with a history of clinical coronary heart disease, heart failure, stroke, diabetes, or chronic kidney disease
* Have lived in a participating village for at least 6 months
* No intention to migrate within next 3 years
* Taking part in the New Rural Cooperative Medical Scheme
* Not pregnant or planning to become pregnant
* No malignant tumors and life expectancy ≥3 years
* Willing to participate and able to sign informed consent
40 Years
ALL
No
Sponsors
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Tulane University
OTHER
First Affiliated Hospital Xi'an Jiaotong University
OTHER
Tongji Hospital
OTHER
Disease Control and Prevention Centre of Liaoning Province
UNKNOWN
Chaoyang Central Hospital
OTHER
Hanzhong People's Hospital
UNKNOWN
Disease Control and Prevention Centre of Chaoyang City
UNKNOWN
Shengjing Hospital
OTHER
First Hospital of China Medical University
OTHER
Responsible Party
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Yingxian Sun
Chief of Department of Cardiology in First Hospital of China Medical University
Principal Investigators
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Yingxian Sun, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
First Hospital of China Medical University
Locations
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The First Hospital of China Medical University
Shenyang, Liaoning, China
Countries
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References
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Sun G, Ye N, Wang C, Liu S, Miao W, Qiao L, Ouyang N, Geng D, Shi C, Zhang L, Zhang P, Yin Y, Xie Z, Yu Y, Sun Y. Evaluating intensive blood pressure control versus usual care on cardiovascular disease in patients with diabetes using win statistics: a subgroup analysis of a cluster randomized trial. J Adv Res. 2025 Sep 29:S2090-1232(25)00758-1. doi: 10.1016/j.jare.2025.09.054. Online ahead of print.
Lu X, Wang J, Chen S, Lv L, Yu J. Effect of Comprehensive Health Management on Medication Adherence and Healthy Lifestyle Behavior of Patients With Hypertension. Int J Hypertens. 2025 Jul 19;2025:1165809. doi: 10.1155/ijhy/1165809. eCollection 2025.
Sun G, Miao W, Liu S, Yin Y, Geng D, Ye N, Xie Z, Zhang L, Zhou S, Wang C, Qiao L, Pei S, Ouyang N, Shi C, Guo X, Sun Y. Intensive Systolic Blood Pressure Reduction and Kidney and Cardiovascular Outcomes: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2025 Jul 1;8(7):e2519604. doi: 10.1001/jamanetworkopen.2025.19604.
He J, Zhao C, Zhong S, Ouyang N, Sun G, Qiao L, Yang R, Zhao C, Liu H, Teng W, Liu X, Wang C, Liu S, Chen CS, Williamson JD, Sun Y. Blood pressure reduction and all-cause dementia in people with uncontrolled hypertension: an open-label, blinded-endpoint, cluster-randomized trial. Nat Med. 2025 Jun;31(6):2054-2061. doi: 10.1038/s41591-025-03616-8. Epub 2025 Apr 21.
Sun G, Guo X, Li G, Zhang P, Yin Y, Qiao L, Ye N, Wang C, Liu S, Geng D, Miao W, Xie Z, Yu Y, Li Z, Jiang X, Tan X, Sun Y. Intensive Blood Pressure Strategy on Cardiovascular Diseases in Patients With Metabolic Syndrome: Post Hoc Analysis of a Clinical Trial. J Am Heart Assoc. 2025 Mar 18;14(6):e036820. doi: 10.1161/JAHA.124.036820. Epub 2025 Mar 13.
Sun G, Wang C, Ye N, Shi C, Ouyang N, Qiao L, Li G, Zhang L, Yu Y, Li Z, Zhou Y, Chen Z, Zhang S, Zhang P, Geng D, Miao W, Liu S, Sun Y. Impact of baseline cardiovascular risk on the outcomes of intensive blood pressure intervention: a post hoc analysis of the China rural hypertension control project. BMC Med. 2024 Jun 20;22(1):258. doi: 10.1186/s12916-024-03494-w.
Guo X, Ouyang N, Sun G, Zhang N, Li Z, Zhang X, Li G, Wang C, Qiao L, Zhou Y, Chen Z, Shi C, Liu S, Miao W, Geng D, Zhang P, Sun Y; CRHCP Study Group. Multifaceted Intensive Blood Pressure Control Model in Older and Younger Individuals With Hypertension: A Randomized Clinical Trial. JAMA Cardiol. 2024 Sep 1;9(9):781-790. doi: 10.1001/jamacardio.2024.1449.
He J, Ouyang N, Guo X, Sun G, Li Z, Mu J, Wang DW, Qiao L, Xing L, Ren G, Zhao C, Yang R, Yuan Z, Wang C, Shi C, Liu S, Miao W, Li G, Chen CS, Sun Y; CRHCP Study Group. Effectiveness of a non-physician community health-care provider-led intensive blood pressure intervention versus usual care on cardiovascular disease (CRHCP): an open-label, blinded-endpoint, cluster-randomised trial. Lancet. 2023 Mar 18;401(10380):928-938. doi: 10.1016/S0140-6736(22)02603-4. Epub 2023 Mar 2.
Sun Y, Mu J, Wang DW, Ouyang N, Xing L, Guo X, Zhao C, Ren G, Ye N, Zhou Y, Wang J, Li Z, Sun G, Yang R, Chen CS, He J; CRHCP Study Group. A village doctor-led multifaceted intervention for blood pressure control in rural China: an open, cluster randomised trial. Lancet. 2022 May 21;399(10339):1964-1975. doi: 10.1016/S0140-6736(22)00325-7. Epub 2022 Apr 29.
Sun Y, Li Z, Guo X, Zhou Y, Ouyang N, Xing L, Sun G, Mu J, Wang D, Zhao C, Wang J, Ye N, Zheng L, Chen S, Chang Y, Yang R, He J. Rationale and Design of a Cluster Randomized Trial of a Village Doctor-Led Intervention on Hypertension Control in China. Am J Hypertens. 2021 Aug 9;34(8):831-839. doi: 10.1093/ajh/hpab038.
Other Identifiers
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KLS20181582
Identifier Type: -
Identifier Source: org_study_id